UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043482 |
|---|---|
| Receipt number | R000049643 |
| Scientific Title | Developmental changes of brain activity related with moral judgment -fMRI study- |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/09/04 09:00:55 |
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Basic information
Public title
Developmental changes of brain activity related with moral judgment -fMRI study-
Acronym
Developmental changes of brain activity related with moral judgment -fMRI study-
Scientific Title
Developmental changes of brain activity related with moral judgment -fMRI study-
Scientific Title:Acronym
Developmental changes of brain activity related with moral judgment -fMRI study-
Region
| Japan |
Condition
Condition
typical developmental children/adults
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Neural network information is measured by DTI (Diffusion tensor imaging), resting-state brain activity information is measured by rs-fMRI (resting-state fMRI), and brain activity information during moral judgment is measured by fMRI.
Basic objectives2
Others
Basic objectives -Others
Information about these brain activities from children, adults, and aged persons will clarify a relationship between brain structures and brain activities about the neutral situation and moral judgment from the viewpoint of development.
Because these results will provide pieces of evidence to moral education, there is a possibility that this study will contribute to constructing a stable society for all generations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age group comparison of BOLD signal changes measured by fMRI during moral judgment
Key secondary outcomes
1. Anti-social personality measured by Japanese ver. of Dark Triad Dirty Dozen
2. personality measured by Japanese ver. of Ten Item Personality Inventory
3. the motivations assumed to underlie forgiving from the Japanese Transgression-Related Interpersonal Motivations Scale
4. Apologizable scale from the Japanese Proclivity to Apologize Measure (J-PAM)
5. Forgiveness scale from the Japanese Trait Forgivingness Scale (J-TFS)
6. IQ from WISC-IV or WAIS-IV
7. Loneliness scale from Japanese UCLA Loneliness Scale
8. brain volumes from VBM
9. neural fiber information from DTI
10. Default mode brain activity from rs-fMRI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
moral judgment to visually presented stimuli(child group)
Interventions/Control_2
moral judgment to visually presented stimuli(adult group)
Interventions/Control_3
moral judgment to visually presented stimuli(aged group)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals who meet the following criteria are eligible.
1. 12-15 years old (mainly junior high school students), 18-24 years old (mainly university students), and 60-65 years old at the time of obtaining consent
2. Those who have obtained consent for this study by signing a consent form by themselves or a substitute.
Key exclusion criteria
Those who meet any of the following conditions will not be included in this study:
1. history of head trauma with disturbance of consciousness for more than 5 minutes
2. History of organic brain disease.
3. History of psychiatric disorders in life history.
4. memory or current symptoms of substance abuse (e.g., alcohol)
5. taking central nervous system agonists (psychotropic drugs, antiepileptic drugs, sleeping pills, etc.)
6. history of clouding of consciousness, convulsive seizures except for febrile convulsions
7. chronic headache symptoms
8. color blindness
9. Those who are unable to undergo an MRI examination.
10. If the researcher judges that the subject is inappropriate for other reasons.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Yasuomi |
| Middle name | |
| Last name | Ouchi |
Organization
Hamamatsu University School of Medicine
Division name
Biofunctional Imaging
Zip code
431-3192
Address
1-20-1,Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2466
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Hiraishi |
Organization
Hamamatsu University School of Medicine
Division name
Biofunctional Imaging
Zip code
431-3192
Address
1-20-1,Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2466
Homepage URL
hiraishi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Medical Photonics Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Hamamatsu University School of Medicine
Address
1-20-1,Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
No.167/C036
Org. issuing International ID_1
Hamamatsu Medical Photonics Foundation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学（静岡県） Hamamatsu University School of Medicine (Shizuoka Pref.)
浜松PET診断センター（静岡県）Hamamatsu PET Imaging Center (Shizuoka Pref.)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Psychological tests and fMRI measurements have been performed on groups of 60-65 yrs and 20-25 yrs in this year term.
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049643
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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